# K090324: Ultrasight HD Digital Colposcopy with Imagesense Technology

- Pathway: 510(k) (Traditional)
- Applicant: Sti Medical Systems
- Decided: Dec 20, 2010 after 679 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955635 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072691: Cervical MD, Model C10, Sti Medical Systems (2008) Summary page 1.

## Most influential descendants
- K110147: Ultrasighthd C31 with Imagesense and Remote Viewer Telemedicine (2011), 0 descendants of its own

## Indications for use
UltraSightHD TM with ImageSense TM is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. OpacityViewer TM is an ImageSense Tm digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.

Source page: https://510kreport.com/device/K090324
Methodology: https://510kreport.com/methodology